An interventional study of History taking and Anthropometry in Acute Myeloid Leukemia, Adult, Cardiotoxicity and Endothelial Dysfunction, sponsored by Samara State Medical University. Completed at 1 site in Russia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Samara State Medical University · Not applicable, Interventional, and Diagnostic
Acute myeloid leukemia (AML) is a clonal neoplastic disease of the hematopoietic tissue associated with a mutation in the precursor cell of hematopoiesis, which results in a differentiation block and uncontrolled proliferation of immature myeloid cells.
Anthracycline antibiotics have been an integral part of the treatment of acute myeloid leukemia since the 1970s. However, the clinical usefulness of anthracyclines is limited primarily by the high incidence of cardiotoxicity. According to the European Society of Cardiology guidelines for cardio-oncology, cardiovascular toxicity is defined as any impairment of cardiac function associated with anticancer treatment, as the term encompasses both a wide range of possible clinical manifestations and an etiological relationship with various treatments, including chemotherapy, radiation therapy, immunotherapy and treatment with targeted drugs. Cardiovascular toxicity can be acute, subacute or delayed, manifesting many years after chemotherapy or radiation therapy, involving a number of cardiac structures, which can lead to the development of heart failure, coronary heart disease, valvular heart disease, arrhythmias, including cardiac conduction disorders and diseases of the pericardium.
Anthracycline-induced cardiotoxicity is the negative effect of anthracyclines on normal cardiac activity due to their toxic effects on the heart muscle and the cardiac conduction system. Anthracycline-induced cardiotoxicity manifests as asymptomatic left ventricular dysfunction in 57% of treated patients and restrictive or dilated cardiomyopathy leading to congestive heart failure (CHF) in 16% to 20% of patients. Anthracycline-induced congestive heart failure is often resistant to therapy and has a mortality rate of up to 79%. Thus, there is a need for early detection of cardiovascular dysfunction associated with chemotherapy treatment of acute myeloid leukemia in order to timely prescribe drug therapy.
Purpose of the study To optimize the early detection of endothelial dysfunction and left ventricular myocardial contractility in patients with acute myeloid leukemia during chemotherapy treatment based on a comprehensive assessment of instrumental and laboratory research parameters.
Expected results Based on a comprehensive analysis using laser Doppler flowmetry, stress echocardiography with the determination of global longitudinal strain of the myocardium, biochemical markers of endothelial damage and cardiac biomarkers, a correlation between violations of the contractility of the left ventricular myocardium and violations of the vasoregulatory function of the vascular endothelium will be revealed, which will allow developing an algorithm for early detection of cardiomyopathy and vascular complications in patients with acute myeloid leukemia during chemotherapy treatment.
Acute myeloid leukemia (AML) is a clonal neoplastic disease of the hematopoietic tissue associated with a mutation in the precursor cell of hematopoiesis, which results in a differentiation block and uncontrolled proliferation of immature myeloid cells.
It is believed that AML affects an average of 3-5 people per 100,000 people per year. At the same time, the incidence increases sharply at the age of over 60 years and amounts to 12-13 cases per 100 thousand of the population in people over the age of 80 years. The median age of this disease is 65 years. With a population of 140 million inhabitants in Russia, the estimated incidence rate (according to European and American researchers) should be about 5 thousand cases.
Anthracycline antibiotics have been an integral part of the treatment of acute myeloid leukemia since the 1970s. Anthracycline is usually given for 3 days (eg, daunorubicin 45-90 mg/m 2 daily, idarubicin 12 mg/m 2 daily) in combination with cytarabine (100-200 mg/m 2 daily) continuously for 7 days ) ("7+3" mode). Anthracyclines block the synthesis of DNA and RNA by inhibiting the enzyme topoisomerase IIβ and mitochondrial topoisomerase I. The subsequent disruption of DNA replication and transcription prevents the proliferation of rapidly dividing cells. In addition, anthracyclines damage DNA, proteins, and cell membranes by creating free oxygen radicals.
The clinical usefulness of anthracyclines is limited primarily by the high incidence of cardiotoxicity. According to the European Society of Cardiology guidelines for cardio- oncology, cardiovascular toxicity is defined as any impairment of cardiac function associated with anticancer treatment, as the term encompasses both a wide range of possible clinical manifestations and an etiological relationship with various treatments, including chemotherapy, radiation therapy, immunotherapy and treatment with targeted drugs. Cardiovascular toxicity can be acute, subacute or delayed, manifesting many years after chemotherapy or radiation therapy, involving a number of cardiac structures, which can lead to the development of heart failure, coronary heart disease, valvular heart disease, arrhythmias, including cardiac conduction disorders, and diseases of the pericardium.
Anthracycline-induced cardiotoxicity is the negative effect of anthracyclines on normal cardiac activity due to their toxic effects on the heart muscle and the cardiac conduction system. It is believed to be mediated in part by reactive oxygen species generated by anthracycline treatment, which leads to lipid peroxidation and DNA damage in cardiomyocytes. Other putative causes of anthracycline-induced cardiotoxicity include accumulation of cardiotoxic anthracycline metabolites in the heart, disruption of calcium homeostasis, mitochondrial damage, and induction of apoptosis.
Anthracycline-induced cardiotoxicity manifests as asymptomatic left ventricular dysfunction in 57% of treated patients and restrictive or dilated cardiomyopathy leading to congestive heart failure (CHF) in 16% to 20% of patients. Anthracycline-induced congestive heart failure is often resistant to therapy and has a mortality rate of up to 79%. Thus, there is a need for early detection of cardiovascular dysfunction associated with chemotherapy treatment of acute myeloid leukemia in order to timely prescribe drug therapy.
Purpose of the study To optimize the early detection of endothelial dysfunction and left ventricular myocardial contractility in patients with acute myeloid leukemia during chemotherapy treatment based on a comprehensive assessment of instrumental and laboratory research parameters.
Research objectives
Scientific novelty
Practical significance It is planned to develop an algorithm for early detection of endothelial dysfunction and left ventricular myocardial contractility in patients with acute myeloid leukemia during chemotherapy treatment based on a comprehensive assessment using laser Doppler flowmetry, stress echocardiography with the determination of global longitudinal myocardial strain, biochemical markers of endothelial damage and cardiac biomarkers. .
Expected results Based on a comprehensive analysis using laser Doppler flowmetry, stress echocardiography with the determination of global longitudinal strain of the myocardium, biochemical markers of endothelial damage and cardiac biomarkers, a correlation between violations of the contractility of the left ventricular myocardium and violations of the vasoregulatory function of the vascular endothelium will be revealed, which will allow developing an algorithm for early detection of cardiomyopathy and vascular complications in patients with acute myeloid leukemia during chemotherapy treatment.
Research hypothesis:
The proposed algorithm for the early detection of cardiovascular complications in patients with acute myeloid leukemia receiving chemotherapy treatment is an effective method for diagnosing cardiovascular complications at subclinical stages for the timely initiation of their therapy.
Study Design In total, it is planned to study 100 patients with acute myeloid leukemia receiving chemotherapy, aged 18 to 65 years, without clinical signs of heart failure, with an LV ejection fraction of more than 50% before the start of polychemotherapy.
The study group will include patients with acute myeloid leukemia receiving chemotherapy, aged 18 to 65 years, without clinical signs of heart failure, with an LV ejection fraction of more than 50% before the start of polychemotherapy, in whom in the course of chemotherapy treatment after the next course of treatment a decrease in global longitudinal strain of 15% or more relative to the initial values will be revealed.
The control group will consist of patients with acute myeloid leukemia receiving chemotherapy, aged 18 to 65 years, without clinical signs of heart failure, with an LV ejection fraction of more than 50% before the start of polychemotherapy, in whom no signs of myocardial disease and endothelial dysfunction will be detected during chemotherapy.
3,667 studies on the registry are indexed under Leukemia, Myeloid, Acute; 816 are open to participants now.
This study's enrollment of 100 is above the median of 40 across 3,005 interventional studies indexed under Leukemia, Myeloid, Acute.
Browse Leukemia, Myeloid, Acute studies →Samara State Medical University is the lead sponsor of 19 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study group will include patients with acute myeloid leukemia receiving chemotherapy, aged 18 to 65 years, without clinical signs of heart failure, with an LV ejection fraction of more than 50% before the start of polychemotherapy, in whom in the course of chemotherapy treatment after the next course of treatment a decrease in global longitudinal strain of 15% or more relative to the initial values will be revealed.
Diagnostic Test: History taking · Diagnostic Test: Anthropometry · Diagnostic Test: Complete blood count · Diagnostic Test: Biochemical blood test · Diagnostic Test: Coagulogram · Diagnostic Test: Immunoenzymatic analysis of the level of endothelin-1, asymmetric dimethylarginine · Diagnostic Test: Stress echocardiography with the definition of global longitudinal deformation of the myocardium · Diagnostic Test: Triplex scanning of neck vessels · Diagnostic Test: Electrocardiography · Diagnostic Test: Ultrasound of the abdominal cavity (with calculation of the area of the spleen) and lymph nodes · Diagnostic Test: Cytogenetic examination of the bone marrow to determine genetic abnormalities. · Diagnostic Test: Cytological examination of bone marrow cells with cytochemical examination · Diagnostic Test: Immunophenotypic examination of the bone marrow by flow cytometry · Diagnostic Test: Determination of the presence of a FLT3 mutation using the PCR Method · Diagnostic Test: laser Doppler flowmetry
The control group will consist of patients with acute myeloid leukemia receiving chemotherapy, aged 18 to 65 years, without clinical signs of heart failure, with an LV ejection fraction of more than 50% before the start of polychemotherapy, in whom no signs of myocardial disease will be detected during chemotherapy. and endothelial dysfunction.
Diagnostic Test: History taking · Diagnostic Test: Anthropometry · Diagnostic Test: Complete blood count · Diagnostic Test: Biochemical blood test · Diagnostic Test: Coagulogram · Diagnostic Test: Immunoenzymatic analysis of the level of endothelin-1, asymmetric dimethylarginine · Diagnostic Test: Stress echocardiography with the definition of global longitudinal deformation of the myocardium · Diagnostic Test: Triplex scanning of neck vessels · Diagnostic Test: Electrocardiography · Diagnostic Test: Ultrasound of the abdominal cavity (with calculation of the area of the spleen) and lymph nodes · Diagnostic Test: Cytogenetic examination of the bone marrow to determine genetic abnormalities. · Diagnostic Test: Cytological examination of bone marrow cells with cytochemical examination · Diagnostic Test: Immunophenotypic examination of the bone marrow by flow cytometry · Diagnostic Test: Determination of the presence of a FLT3 mutation using the PCR Method · Diagnostic Test: laser Doppler flowmetry
Careful history taking, including using questionnaires, to identify risk factors for the development of cardiovascular diseases using the SCORE scale.
Anthropometry: measurement of body weight and height. Calculation of body surface area using the Du Bois formula.
Before and after each course of chemotherapy: Complete blood count with counting the number of erythrocytes, leukocytes, leukocyte formula, platelets, erythrocyte sedimentation rate.
Before and after each course of chemotherapy: Biochemical blood test with the determination of the amount of total protein, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, creatinine, urea, AlAT, AsAT, LDH, glucose, C-reactive protein, troponin T, proBNP.
Before and after each course of chemotherapy: Coagulogram parameters (fibrinogen, APTT, INR).
Before the start of the treatment and after each course of chemotherapy: Immunoenzymatic analysis of the level of endothelin-1, asymmetric dimethylarginine.
Before the start of the treatment and after each course of chemotherapy: Stress echocardiography with the definition of global longitudinal deformation of the myocardium.
Before the start of the treatment and after each course of chemotherapy: Triplex scanning of neck vessels.
Before and after each course of chemotherapy: Electrocardiography.
Before the start of the treatment and after each course of chemotherapy: Ultrasound of the abdominal cavity (with calculation of the area of the spleen) and lymph nodes.
Before the start of the treatment: Cytogenetic examination of the bone marrow to determine genetic abnormalities.
Before the start of the treatment and after each course of chemotherapy: Cytological examination of bone marrow cells with cytochemical examination.
Before the start of the treatment: Immunophenotypic examination of the bone marrow by flow cytometry.
Before the start of the treatment: Determination of the presence of a FLT3 mutation using the PCR Method.
Before the start of the treatment and after each course of chemotherapy: Examination of microcirculation by laser Doppler flowmetry using the LAKK-OP apparatus (NPP Lazma, Moscow, 2011) with respiratory and occlusion tests.
Change of global longitudinal strain of 15% or more relative to the initial values
Change of global longitudinal strain of the myocardium according to stress echocardiography by 15% or more relative to the values obtained before the start of chemotherapy treatment.
Time frame: Evaluation is carried out within 1 week after each course of chemotherapy up to 10 months, evaluated after each course of induction of remission and consolidation of remission.
Change of the index of microcirculation according to laser Doppler flowmetry
Change of the microcirculation index according to the results of laser Doppler flowmetry in relation to the values obtained before the start of chemotherapy treatment.
Time frame: Evaluation is carried out within 1 week after each course of chemotherapy up to 10 months, evaluated after each course of induction of remission and consolidation of remission.
Change of the Coefficient of Variation of Microcirculation According to Laser Doppler Fluometry
Change of the coefficient of variation of microcirculation according to the results of laser Doppler flowmetry in relation to the values obtained before the start of chemotherapy treatment.
Time frame: Evaluation is carried out within 1 week after each course of chemotherapy up to 10 months, evaluated after each course of induction of remission and consolidation of remission.
Change of the level of highly sensitive T-troponin
Change of the level of highly sensitive T-troponin, which goes beyond the reference values, in relation to the values obtained before the start of chemotherapy treatment.
Time frame: Evaluation is carried out within 1 week after each course of chemotherapy up to 10 months, evaluated after each course of induction of remission and consolidation of remission.
Change of brain natriuretic peptide level
Change of the level of brain natriuretic peptide that goes beyond the reference values, in relation to the values obtained before the start of chemotherapy treatment.
Time frame: Evaluation is carried out within 1 week after each course of chemotherapy up to 10 months, evaluated after each course of induction of remission and consolidation of remission.
Change of the level of asymmetric dimethylarginine
Change of the level of asymmetric dimethylarginine that goes beyond the reference values, in relation to the values obtained before the start of chemotherapy treatment.
Time frame: Evaluation is carried out within 1 week after each course of chemotherapy up to 10 months, evaluated after each course of induction of remission and consolidation of remission.
Change of the level of endothelin-1
Change of the level of endothelin-1, which goes beyond the reference values, in relation to the values obtained before the start of chemotherapy treatment.
Time frame: Evaluation is carried out within 1 week after each course of chemotherapy up to 10 months, evaluated after each course of induction of remission and consolidation of remission.
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Dec 2022 to primary completion in Jan 2025, 25 months.
Of 132 non-industry interventional studies with no phase under Leukemia, Myeloid, Acute, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 128. This study's 25 months is below that.
Counting every sponsor, half of 139 studies reached it within 47 months; a quarter within 25 and three quarters within 123.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Samara State Medical University